MAUDE Adverse Event Report: DENTSPLY DETREY GMBH AH PLUS JET STARTER KIT; RESIN, ROOT CANAL FILLING

Model Number	60620115
Medical Device Problem Code	Material Too Soft/Flexible (4007)
Health Effect - Clinical Code	Pain (1994)
Date of Event	06/19/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
In this event it is reported that ah plus jet starter kit used in treatment of root canal filling doctor noticed that the consistency was too liquid and had a rotten egg smell.After treatment the patient complained of pain.The filling was removed and replaced; the filling material removed was found to be crumbly according to the doctor.
Additional Manufacturer Narrative
Since this event resulted in medical/surgical intervention to preclude permanent damage to a body structure or permanent impairment of a body function, it must be presumed that the malfunction would be likely to cause or contribute to a serious injury should it recur.As such, this event meets the definition of a reportable event per 21 cfr part 803.The device is available for evaluation, though results are not available as of this report.Evaluation results will be submitted as they become available.
Additional Manufacturer Narrative
Investigation results: returned sample was examined.Results are within specification and can be found in the attachment.The smell of the material is very characteristic.To exclude the possibility that other ingredients are contained in it, an ir spectrum was made.The result is also in the attachment and is within the specification.Complaint cannot be confirmed.The dhr of the complained batch was checked.There were no abnormalities in the dhr.Root cause: no defect proven.Conclusion code: no failure found.

• Brand Name: AH PLUS JET STARTER KIT
• Common Device Name: RESIN, ROOT CANAL FILLING
• Manufacturer (Section D): DENTSPLY DETREY GMBH; detrey strasse 1; konstanz baden-wurttemberg 78467 ; GM 78467
• Manufacturer (Section G): DENTSPLY DETREY GMBH; detrey strasse 1; konstanz baden-wurttemberg 78467 ; GM 78467
• Manufacturer Contact: hannah seevaratnam ; 221 west philadelphia st.; york, PA 17401 ; 7178457511
• MDR Report Key: 17224537
• Report Number: 8010638-2023-00023
• Device Sequence Number: 15264290
• Product Code: KIF
• UDI-Device Identifier: D010606201151
• UDI-Public: D010606201151
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 09/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 02/29/2024
• Device Model Number: 60620115
• Device Catalogue Number: 60620115
• Device Lot Number: 2202000683
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 06/26/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/26/2023
• Supplement Date Received by Manufacturer: 06/26/2023
• Initial Report FDA Received Date: 06/29/2023
• Supplement Report FDA Received Date: 09/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown